Quality Manager-Med Devices
Opportunity to join an industry leader in Medical Devices
Will manage a team of engineers
About Our Client
Our client is a digital health med tech company and is developing integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from advanced heart failure.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Quality Manager will be responsible for:
- Managing the Quality Management System processes that include: Document Control, Training, Internal/External Auditing, CAPA and Non-conformance's
- Manage external and internal customers to ensure quality products
- Oversees all internal Quality Management System audit planning, preparation, execution, reporting, responses and follow ups
- Partners with functional leaders to identify and proactively address areas for improvement within the Quality Management System
- Facilitates FDA and other regulatory agency and notified body inspections
The Successful Applicant
The successful candidate will:
- Bachelor's Degree in Engineering, Science or Related Field
- 7+ years of experience in a Quality Assurance environment, medical device preferred
- Minimum 5 years of experience managing a quality team of engineers, technicians, etc.
- Working knowledge of ISO 13485
- Experience in a development of medical Quality Management System
What's on Offer
- Competitive pay - based on experience
- Aggressive performance bonus structures and world-class benefits
- A Safety-focused and Quality-focused work environment
- Company culture that is flexible and focused on personal accountability